The Icahn School of Medicine at Mount Sinai in the US has commenced a Phase I clinical trial of an investigational egg-based Covid-19 vaccine in healthy and vaccinated adult subjects.
Developed by Icahn School of Medicine researchers, the NDV-HXP-S vaccine contains a recombinant Newcastle disease virus that expresses the SARS-CoV-2 virus spike protein.
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The vaccine has no adjuvants or preservatives and could possibly offer added immunity against Covid-19.
The open-label, placebo-controlled trial will analyse the safety and immunogenicity of the vaccine versus placebo.
It will enrol nearly 35 healthy subjects aged between 18 and 59 years who received the last dose of their Covid-19 vaccine as part of the initial regimen or booster over six months ago.
Furthermore, these study participants should have never been infected with Covid-19.
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By GlobalDataIn the trial, the study subjects will be given one of two dose levels of the vaccine intramuscularly, intranasally, or a combination of intranasal/intramuscular administration or placebo.
Apart from this US trial, the vaccine was or is presently being analysed in trials in Brazil, Mexico, Vietnam and Thailand.
Mount Sinai Infectious Diseases, Hospital Medicine assistant professor Dr Sean Liu said: “Our microbiology team has a particular and impressive breadth of expertise in the understanding, evaluation, and development of RNA viruses and vaccines.
“Now, our independent clinical research team is eager to do the rigorous, objective scientific work needed to evaluate this investigational vaccine.
“To that end, multiple safeguards have been implemented in order to protect the research objectivity and oversight of this clinical trial, so we are poised to begin and enrolment is currently open.”
